Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACCESS Supportive Care, Phone sessions.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer, Stage IV Breast Cancer AJCC V7. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Overview
Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.
Detailed description
Primary Objectives:
1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer. 2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services.
OUTLINE: Participants (N=60) are randomized to 1 of 2 groups:
GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.
GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.
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Interventions
- Behavioral ACCESS Supportive Care
ACCESS Supportive Care includes: 1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connectio - Behavioral Phone sessions
6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.
Primary outcome measures
- Number of participants recruited [Time frame: at 9 months]
- Number of participants remaining in study [Time frame: at 9 months]
- Number of times navigator communicates with oncology team [Time frame: 9 months]
- Number of times participants connect to resources [Time frame: 9 months]
- Number of visits [Time frame: 6 months]
- Number of phone calls [Time frame: 9 months]
- Number of visits conducted according to the ACCESS manual [Time frame: 9 months]
- Change in The Impact of Event Scale - Revised (IES-R) scores [Time frame: Baseline and 9 months]
- Change in The Memorial Symptom Assessment Scale (MSAS) [Time frame: Baseline and 9 months]
Eligibility criteria
Inclusion criteria
- Women ≥18 years of age
- English and/or Spanish speaking
- Self-identify as Latina and/or African American/Black
- Ability to understand and the willingness to sign a written informed consent
- Stage IV breast cancer diagnosis, no time component
Exclusion criteria
- Moderate to severe cognitive impairment
- receiving inpatient hospice care
- if patients were previously enrolled in Aim 1 and Aim 2
- currently working with a community navigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mount Sinai Hospital — New York
Identifiers
NCT: NCT06405828 · Study-21-01250 · K08CA267309